FDA premarket cybersecurity submission services aligned to the FDA February 2026 final guidance and Section 524B.
Every artifact the FDA expects in a premarket cybersecurity submission - SPDF, SBOM with VEX, threat model, penetration test report, and Section 524B attestation - delivered eSTAR-ready by a senior US-based team. Aligned to the FDA February 2026 final premarket cybersecurity guidance. 250+ FDA submissions supported, zero cybersecurity rejections.
Not sure which package fits? Compare in 10 seconds:
510(k) submission
Predicate-based clearance. Cybersecurity section sized to a 510(k) eSTAR.
Premarket, any pathway
Full cyber package for 510(k), De Novo, or PMA. Start here if pathway is TBD.
PMA & De Novo
Higher-risk. Multi-patient harm view + fielded postmarket program at filing.
Section 524B compliance
Cyber device? SPDF + SBOM + postmarket + CVD proven to the 524B statute.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork.”
Amy Lynn, Chief Compliance Officer, Medivis
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
Built to the February 2026 final premarket cybersecurity guidance. Every artifact maps to the section the FDA reviewer is looking for.
Drops directly into eSTAR for 510(k), De Novo, and PMA submissions - no reformatting, no missing attachments, no acceptance-checklist surprises.
SPDF integrated into your QMSR (21 CFR 820) and ISO 13485 processes with full traceability from requirement to verification evidence.
Machine-readable SPDX or CycloneDX SBOM with NTIA minimum elements (now stewarded by CISA), support-end dates, and a VEX statement for every CVE in your shipping configuration.
End-to-end STRIDE threat model with multi-patient harm, updateability, and use-environment views. Aligned to AAMI TIR57 and ANSI/AAMI SW96.
Fixed fee. Retests and revisions are included until the cybersecurity portion of your submission is closed. No per-cycle invoices.
These are the issues showing up in real FDA acceptance-checklist holds and cybersecurity deficiency letters under the February 2026 final guidance.
Premarket package lacks a vulnerability monitoring + coordinated vulnerability disclosure plan. Required for every cyber device.
Bare SBOM ships with unresolved CVEs and no exploitability analysis. Reviewer requires VEX for every applicable vulnerability.
STRIDE entries exist but no mapping to mitigations, test evidence, or residual risk. Reviewer requests full SW96 / TIR57 traceability matrix.
Device firmware tested but cloud backend, mobile companion, and wireless interfaces skipped. Reviewer requires every interface in scope.
Secure Product Development Framework not integrated into existing QMSR / ISO 13485 design controls. Reviewer flags missing traceability.
Artifacts ship without a narrative tying threat model, controls, and test evidence into a defensible reasonable-assurance conclusion.
What you actually get versus a generic 510(k) consultant or building the cybersecurity package in-house.
| Capability | Blue Goat Cyber | Generic 510(k) consultant | In-house |
|---|---|---|---|
| Mapped to FDA February 2026 final guidance + 524B | Section-by-section, reviewer-format | Legacy template, often out of date | Built from scratch each submission |
| SPDF + threat model + SBOM + VEX | All deliverables, one team | Outsourced piecemeal across vendors | Multiple internal owners, gaps emerge |
| FDA submission track record | 250+ submissions, zero cyber rejections | Limited cyber-specific experience | First-submission risk |
| Pricing model | Fixed fee, unlimited revisions until accepted | Hourly + change orders | Hidden internal cost |
| Mutual NDA before first call | Standard, signed day 0 | Usually after SOW | n/a |
We sign a mutual NDA, then walk your device, submission type, and the cybersecurity evidence the FDA reviewer will expect.
Point-by-point gap list against Section 524B and the FDA February 2026 final guidance, each gap mapped to the artifact that closes it, with a fixed-fee quote covering every deliverable.
SPDF, SBOM with VEX, threat model, pen test report, and cybersecurity labeling - delivered in eSTAR-attachable format, reviewer-ready.
"Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork. The organized documentation, perfectly formatted for eSTAR, saves us countless hours."
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 250+ FDA submissions, zero cybersecurity rejections to date.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
No sales pressure. After the call, you get a concrete written strategy mapped to Section 524B and the FDA February 2026 final guidance.
Senior-led delivery on every FDA-facing artifact. No offshoring, no hourly billing. Unlimited revisions. Every artifact is eSTAR-ready.
Who you're talking to
MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity
Christian leads the senior medical device cybersecurity team behind 250+ FDA submissions, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30 minutes with a senior medical device cybersecurity engineer. Mutual NDA signed before the call. No pitch - we'll tell you straight if you don't need us.
Deeper analysis on the artifacts, standards, and documentation the FDA reviewer expects inside a premarket cybersecurity submission.
Navigating the FDA clearance process for medical devices involves more than technical documentation and testing - it involves significant regulatory.
Read the analysisThe 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.
Read the analysisFDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.
Read the analysisCybersecurity Metrics for FDA Compliance for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
Read the analysisPremarket Cybersecurity Insider Tips: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read the analysis